Safety and Efficacy of a Sublingual Specific Immunotherapy With an Extract of a Six Grass Pollen Mixture
|The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.|
|ClinicalTrials.gov Identifier: NCT00264459|
Recruitment Status : Completed
First Posted : December 13, 2005
Last Update Posted : January 24, 2014
|Condition or disease||Intervention/treatment||Phase|
|Grass Pollen Allergy||Biological: Grass pollen formulation Other: Comparator||Phase 3|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||160 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)|
|Official Title:||A Multicentre, Placebo-controlled, Double-blind Study to Evaluate Efficacy and Safety of a Perennial Sublingual Specific Immunotherapy With a Liquid Formulation of an Extract of a Six Grass Pollen-mixture in Patients With Clinically Relevant Grass Pollen Sensitivity.|
|Study Start Date :||February 2003|
|Actual Primary Completion Date :||August 2008|
|Actual Study Completion Date :||September 2011|
Placebo Comparator: Placebo
Placebo was given the same way as a sublingual preparation.
Solution for sublingual application containing Placebo. The study solution was applied sublingually, kept under the tongue for 3 minutes, and swallowed thereafter.
Other Name: Specific Immunotherapy
Experimental: Liquid formulation of an extract of a 6 grass pollen mixture
Sublingual application containing allergen extracts of 6 grass pollen species (Holcus lanatus, Dactylus glomerata, Lolium perenne, Phleum pratense, Poa pratensis, Festuca pratensis) pollen allergen extract.
The study solution was applied sublingually, kept under the tongue for 3 minutes, and swallowed thereafter. Initial treatment was applied on the first day of treatment with a starting dose of 25% of the maintenance dose. Increasing doses of 50% were applied with the second and 100% with the third dose to give the maximum (=maintenance) dose. This was followed by a daily patient selfadministered treatment with the maintenance dose.
Biological: Grass pollen formulation
Solution for sublingual application containing allergen extracts of 6 grass pollen species (Holcus lanatus, Dactylus glomerata, Lolium perenne, Phleum pratense, Poa pratensis, Festuca pratensis) pollen allergen extract.
The study solution was applied sublingually, kept under the tongue for 3 minutes, and swallowed thereafter.
Other Name: specific immunotherapy
- Symptom and Medication Score (SMS) [ Time Frame: 1.5 years of therapy ]The primary endpoint is the change of the area under the curve (AUC, derived from an analysis period of 42 days) of the daily sum of the Symptom and Medication Score (SMS) from the baseline measurement to the measurement after 1.5 years of therapy.
- Visual Rating Scale [ Time Frame: 1.5 years ]Patients' Assessment of severity of symptoms at the end of each season on a 10 points visual rating scale (VRS)
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00264459
|Allergopharma GmbH & Co. KG|
|Reinbek, Germany, 21465|
|Principal Investigator:||Ludger Klimek, M.D.|